A traditional Chinese medicine preparation for warming meridians, dispelling cold, promoting blood circulation and relieving pain and a preparation method thereof
By rationally combining 10 kinds of Chinese medicinal herbs, including Banbianqi, a topical Chinese medicine preparation has been developed, which solves the problems of short analgesic time and adverse reactions of existing Chinese medicine preparations and Western medicine, and achieves long-lasting analgesia and anti-inflammatory and swelling-reducing effects.
Patent Information
- Application Number
- CN202610203612.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-02-12
- Publication Date
- 2026-05-29
AI Technical Summary
Existing traditional Chinese medicine preparations for treating pain in cold-dampness arthralgia have drawbacks such as complex composition, short duration of analgesia, and easy recurrence, while Western medicine treatments have problems with adverse reactions and drug addiction.
Ten kinds of Chinese medicinal herbs, including Banbianqi, Shancigu, Tianwencao, and Zijingpi, are combined to form external dosage forms such as tinctures and emulsions. Through steps such as heating to extract volatile oils and decoction to concentrate, and with the addition of excipients such as polyethylene glycol and menthol, the pH value is adjusted to form a Chinese medicine preparation that warms the meridians, dispels cold, promotes blood circulation, and relieves pain.
It significantly increases the pain threshold, prolongs the pain latency period, and significantly reduces the frequency of pain. It has long-lasting analgesic and anti-inflammatory effects, and is significantly superior to existing positive control drugs.
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Figure CN122097510A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceutical, and particularly relates to a traditional Chinese medicine preparation for warming meridians and dispelling cold, promoting blood circulation to remove pain and its preparation method. Background Art
[0002] Traditional Chinese medicine classifies most joint discomfort into the category of "Bi syndrome". The pronunciation of the character "Bi" is the same as "Bi", and its meaning can be simply understood as "blocked". The human meridians are blocked by pathogenic factors, the channels are blocked, the qi and blood circulation is unfavorable or the qi mechanism of the zang-fu organs is not smooth, thus causing a series of symptoms, often mainly manifested as joint and muscle numbness, body pain and other symptoms. Through traditional Chinese medicine syndrome differentiation, Bi syndrome can be mainly divided into cold-dampness obstruction type, wind-dampness heat stagnation type, phlegm-blood stasis intermingling type, kidney deficiency cold coagulation type, etc., among which the cold-dampness obstruction type is the most common. Cold-dampness Bi syndrome is caused by the invasion of damp pathogen toxin and cold pathogen toxin into the human body, involving tissues such as joints, tendons and bones, and muscles, resulting in symptoms such as joint swelling, pain, and limited flexion and extension. The middle-aged and elderly are the high-incidence population of this kind of disease. Bi syndrome has a slow onset and is difficult to cure. Patients often have repeated attacks of the disease due to being invaded by wind-cold-damp pathogen, with persistent pain, and then evolve into chronic pain, which affects the physical and mental health of patients for a long time. At present, the treatment of pain caused by cold-dampness Bi syndrome mainly relies on non-steroidal anti-inflammatory drugs, central nervous system inhibitors, etc. Although it can play a certain therapeutic role, there are also problems such as adverse reactions and drug addiction. Traditional Chinese medicine has a long history of treating Bi syndrome pain. Many research reports show that both external treatment and internal administration of traditional Chinese medicine have achieved good therapeutic and improvement effects. At present, there are many traditional Chinese medicine preparations for Bi syndrome on the market, but they have disadvantages such as complex ingredients, short pain relief and analgesic effect time, and easy recurrence. The present invention aims to provide a traditional Chinese medicine external preparation for treating or relieving the pain of cold-dampness Bi syndrome, which can continuously relieve pain and has a definite curative effect, and has the functions of warming meridians and dredging collaterals, promoting blood circulation to remove stasis, dispelling cold and dampness, and detumescence and pain relief. Summary of the Invention
[0003] (I) Technical Problems to be Solved
[0004] In view of the deficiencies of the prior art, the present invention provides a traditional Chinese medicine preparation for warming meridians and dispelling cold, promoting blood circulation to remove pain and its preparation method.
[0005] (II) Technical Solutions
[0006] To achieve the above object, the present invention is realized through the following technical solutions:
[0007] In a first aspect, the present invention provides a traditional Chinese medicine preparation for warming the meridians, dispelling cold, promoting blood circulation, and relieving pain. The traditional Chinese medicine preparation is made from the following traditional Chinese medicinal materials in parts by weight: 30-60 parts of *Banbianqi*, 20-50 parts of *Shancigu*, 30-60 parts of *Tianwencao*, 30-60 parts of *Zijingpi*, 30-60 parts of *Shufu*, 30-60 parts of *Shuitianqi*, 30-60 parts of *Shibazheng*, 30-60 parts of *Ligenxiang*, 30-60 parts of *Jiejiecha*, 30-60 parts of *Xuchangqing*, 30-60 parts of *Yunlanxiang*, 30-60 parts of *Baimu*, 30-60 parts of *Ligusticum striatum*, 20-50 parts of *Zhuifengsan*, 20-50 parts of *Shanhaitang*, 20-50 parts of *Dengzhanxixin*, and 20-50 parts of borneol.
[0008] Preferably, the traditional Chinese medicine preparation is made from the following traditional Chinese medicinal materials in parts by weight: 40-60 parts of *Banbianqi*, 25-45 parts of *Shancigu*, 40-60 parts of *Tianwencao*, 40-60 parts of *Zijingpi*, 40-60 parts of *Shufu*, 40-60 parts of *Shuitianqi*, 40-60 parts of *Shibazheng*, 40-60 parts of *Ligenxiang*, 40-60 parts of *Jiejiecha*, 40-60 parts of *Xuchangqing*, 40-60 parts of *Yunlanxiang*, 40-60 parts of *Baimu*, 40-60 parts of *Ligusticum striatum*, 25-45 parts of *Zhuifengsan*, 25-45 parts of *Shanhaitang*, 25-45 parts of *Dengzhanxixin*, and 25-45 parts of borneol.
[0009] Preferably, the traditional Chinese medicine preparation is made from the following traditional Chinese medicinal materials in parts by weight: 50 parts of *Banbianqi*, 30 parts of *Shancigu*, 55 parts of *Tianwencao*, 55 parts of *Zijingpi*, 45 parts of *Shufu*, 45 parts of *Shuitianqi*, 50 parts of *Shibazheng*, 45 parts of *Ligenxiang*, 45 parts of *Jiejiecha*, 50 parts of *Xuchangqing*, 55 parts of *Yunlanxiang*, 50 parts of *Baimu*, 45 parts of *Ligusticum striatum*, 35 parts of *Zhuifengsan*, 30 parts of *Shanhaitang*, 30 parts of *Dengzhanxixin*, and 35 parts of borneol.
[0010] The present invention provides a traditional Chinese medicine preparation for warming the meridians and dispelling cold, and promoting blood circulation. It is made from the above-mentioned parts by weight of Chinese medicinal materials as raw materials, supplemented with pharmaceutically acceptable excipients, and prepared into an external dosage form. The external dosage form includes any one of tincture, emulsion, ointment, liniment, patch, spray, oil, powder, lotion, and paste.
[0011] Secondly, the present invention provides a method for preparing a traditional Chinese medicine preparation that warms the meridians, dispels cold, and invigorates blood circulation. The traditional Chinese medicine preparation is prepared according to the following steps:
[0012] (1) Weigh the spearmint according to the above weight proportions, crush it into coarse powder, pass it through a No. 2 sieve, put it into a volatile oil extractor, add 8-10 times the amount of purified water, heat and reflux for more than 4 hours to extract the volatile oil, collect the volatile oil and set it aside; keep the residue for later use.
[0013] (2) Weigh out the following ingredients according to the above weight proportions: half-flavor flag, mountain wormwood, astronomical grass, red thorn bark, woodlice, water ginseng, eighteen kinds of disease, root-leaved incense, jointed tea, Xu Changqing, white wood, fan palm seed, wind-chasing umbrella, mountain crabapple, and lamp lanceolata. Grind them into coarse powder, pass them through a No. 2 sieve, and mix them evenly with the residue from step (1). Add 10-12 times the amount of purified water, soak for more than 1 hour, heat and decoct to extract 3 times. The first decoction is 1.5-2 hours, the second is 1-1.5 hours with 8-10 times the amount of purified water, and the third is 1-1.5 hours with 8-10 times the amount of purified water. Combine the 3 decoctions, filter, and remove the residue. Concentrate the decoction under reduced pressure to a thick extract with a relative density of 1.20-1.25 for later use.
[0014] (3) Matrix preparation: Take 100-150 parts by weight of polyethylene glycol 4000, heat it at 80-85℃ until it is completely melted, then add 150-200 parts by weight of polyethylene glycol 400, stir evenly, keep warm at 80-85℃, add 30-40 parts by weight of butanediol, 20-30 parts by weight of 1,2-hexanediol, 5-15 parts by weight of azone, and 5-15 parts by weight of menthol, stir until completely dissolved, then add 0.5-1.5 parts by weight of ethylparaben, stir until dissolved, then slowly add 40-70 parts by weight of purified water, stir evenly, keep warm for later use;
[0015] (4) Slowly add the thick extract prepared in step (2) to the matrix prepared in step (3), stir evenly, cool down to below 40°C, then add the peppermint volatile oil and spearmint volatile oil prepared in step (1), stir evenly, add borneol powder with a particle size of 150-200 mesh, continue stirring for more than 20 minutes to obtain the Chinese medicine paste.
[0016] (5) Adjust the pH of the herbal paste to 6.0-7.0 with triethanolamine, and continue stirring until the temperature of the paste drops below 30°C to obtain the herbal preparation.
[0017] The sources and pharmacological effects of the various Chinese medicinal materials in the traditional Chinese medicine preparations described in this invention are introduced below:
[0018] Half-flag: The dried whole herb of Pteris semipinnata, a plant of the Pteridaceae family. It is bitter and cold in nature, and enters the liver meridian. It has the effects of clearing heat and detoxifying, cooling blood and stopping bleeding, reducing swelling and dissipating nodules. It is often used for sore throat, carbuncles and boils, and bleeding due to blood heat.
[0019] Mountain Pseudobulb: The dried pseudobulb of *Cremastra appendiculata* (D. Don) Makino, *Pleione bulbocodioides* (Franch.) Rolfe, or *Pleione yunnanensis* Rolfe, belonging to the Orchidaceae family. It is cool in nature, sweet and slightly pungent in taste, and enters the liver and spleen meridians. It clears heat and detoxifies, resolves phlegm and disperses stagnation. It is used for carbuncles, boils, scrofula, snake and insect bites, and abdominal masses.
[0020] Astronomical Grass: Another name for the plant Spilanthes paniculata (scientific name: Spilanthes paniculata) of the Asteraceae family, also known as Thousand-Day Grass or Blood-Dispersing Grass; the whole plant is used as medicine. Traditional medicine believes that it has the effects of clearing heat and detoxifying, reducing swelling and relieving pain, dispelling wind and dampness, and is often used to treat rheumatic pain, traumatic injuries, toothache and skin infections.
[0021] Bauhinia bark: The dried bark of the Bauhinia tree (Cercis chinensis), a legume. It is bitter and neutral in nature, and enters the liver and spleen meridians. It has the effects of promoting blood circulation and regulating menstruation, reducing swelling and relieving pain, and detoxifying. It is often used to treat injuries from falls and blows, rheumatic pain, carbuncles and boils.
[0022] Woodlice: The dried whole body of the woodlice beetle (Platycladus orientalis); it is sour and cool in nature, enters the Jueyin meridian, and has the effects of breaking up blood stasis, promoting diuresis, detoxifying and relieving pain. It is mainly used to treat amenorrhea, abdominal masses, chronic malaria, urinary retention, infantile convulsions, toothache, and thrush.
[0023] *Schizocapsa plantaginea* Hance Tacca plantaginea (Hance) Drenth., belonging to the genus *Schizocapsa* of the family Dioscoreaceae (Arachnaceae, Saxifragaceae), is used medicinally for its tubers. It is bitter and cold in nature; its functions include clearing heat and detoxifying, dispersing blood stasis and reducing swelling, regulating qi and relieving pain, and treating malaria. It is used for sore throat, acute gastroenteritis, urinary tract infections, toothache, chronic gastritis, gastric and duodenal ulcers, rheumatoid arthritis, irregular menstruation, malaria, and traumatic injuries; externally, it is used to treat sores, boils, and external bleeding.
[0024] Eighteen Symptoms: The whole plant of *Boehmeria nivea*, a plant in the Piperaceae family; pungent and warm; dispels wind and cold, relieves pain and relieves discomfort; treats rheumatic pain, traumatic swelling and pain, stomach pain due to cold; and snake and centipede bites.
[0025] Calogyne pilosa R.Br., a plant in the Calogyneceraceae family, is a pungent and warm plant that enters the liver and spleen meridians. It is used to dispel wind and cold, promote qi and blood circulation, and detoxify snake venom. It is commonly used for wind-cold arthralgia, stomachache, abdominal pain, traumatic injuries, and snake bites.
[0026] Jointed Tea: The whole plant of *Chloranthus officinalis* Blume, belonging to the genus *Chloranthus* of the family Chloranthaceae, is used medicinally. It is pungent, slightly bitter, and warm in nature; it promotes blood circulation, stops bleeding, and relieves pain. It is used for colds, kidney stones, uterine prolapse, postpartum hemorrhage, epilepsy, injuries from falls and strains, rheumatic numbness, arthritis, and migraines; externally, it is used to treat fractures.
[0027] Xu Changqing: The dried root and rhizome of Xu Changqing, a plant in the Asclepiadaceae family. It is pungent and warm in nature, and enters the liver and stomach meridians. It has the effects of dispelling wind and dampness, relieving pain, relieving itching, and detoxifying. It is widely used to treat rheumatic pain, traumatic injuries, eczema, snake bites, and other diseases.
[0028] Spearmint: The whole herb of spearmint, a plant in the Lamiaceae family; its functions and indications are: dispelling wind, regulating qi, and relieving pain. It is used for colds, coughs, headaches, abdominal distension and pain, and dysmenorrhea.
[0029] White wood: The root or leaves of the Rutaceae plant *Cynanchum paniculatum*; pungent; bitter; warm in nature; enters the liver and kidney meridians; invigorates blood circulation and promotes qi flow; disperses blood stasis and relieves pain. Mainly used for chest pain; traumatic swelling and pain; fractures; sprains; rheumatic pain; pain caused by illness; and snake bites.
[0030] Livistona chinensis seeds are the dried seeds of an evergreen tree (scientific name: Livistona chinensis (Jacq.) R.Br.) belonging to the palm family. They are sweet, bitter and neutral in nature, and enter the lung, liver, kidney and stomach meridians. They have the effects of promoting blood circulation and removing blood stasis, softening hard masses and dispersing nodules. They are mainly used to treat chronic hepatitis and abdominal masses.
[0031] *Lysimachia paridiformis* Franch. var. *stenophylla* Franch. (Primulaceae family): The whole herb or root of this plant. It has a pungent taste and warm properties; it is used to dispel wind, unblock meridians, promote blood circulation, and relieve pain. It is used for rheumatic pain, hemiplegia, infantile convulsions, injuries, and fractures.
[0032] Mountain crabapple: The whole herb, root, or fruit of *Begonia yunnanensis*, a plant in the Begoniaceae family. It is pungent and warm in nature; its functions and indications are: promoting qi circulation and relieving pain, invigorating blood and removing blood stasis. It is used to treat stomach pain, irregular menstruation, dysmenorrhea, infantile vomiting and diarrhea, hernia, and traumatic injuries.
[0033] Asarum sieboldii: The dried whole herb of Erigeron breviscapus, a plant of the Asteraceae family; it is pungent, slightly bitter, and warm in nature, and enters the heart and liver meridians. It has the effects of promoting blood circulation, relieving pain, dispelling wind and cold, and is mainly used to treat hemiplegia due to stroke, chest pain, rheumatic pain, headache, toothache, etc.
[0034] Borneol is obtained by steam distillation and recrystallization of the stems and leaves of *Artemisia argyi* (Asteraceae family) or the branches and leaves of *Cinnamomum camphora* (Lauraceae family). It is pungent, bitter, and slightly cold in nature. It enters the heart, spleen, and lung meridians. It has a clear and dispersing aroma and has the effects of opening the orifices and refreshing the mind, clearing heat and detoxifying, and improving eyesight and removing corneal opacity. It is mainly used to treat high fever and delirium due to febrile diseases, stroke with phlegm syncope and epilepsy, summer heat and dampness obscuring the clear orifices, sore throat and deafness, oral ulcers and tooth swelling, sores, carbuncles, hemorrhoids, red and swollen eyes, and corneal opacity.
[0035] (III) Beneficial Effects
[0036] Traditional Chinese medicine believes that the core pathogenesis of cold-dampness obstruction type arthralgia lies in the stagnation of cold and dampness, obstruction of meridians, and blood stasis and qi stagnation. Therefore, this invention follows the treatment principles of warming and dispersing cold, dispelling wind and dampness, promoting blood circulation and unblocking meridians, and relieving pain and swelling. The formula is derived by rationally combining the principal, assistant, and adjuvant herbs. In this formula, the eighteen herbs (specifically, *Eighteen Symptoms*) have a strong effect in dispelling wind and cold, promoting blood circulation and unblocking meridians, and relieving pain, making them essential for treating cold-dampness arthralgia. *Chasing Wind Umbrella* (a type of herb) warms and unblocks meridians, dispels wind and dampness, and can break up the stagnation of cold and dampness. *Mountain Crabapple* (another herb) promotes qi circulation, relieves pain, promotes blood circulation and removes blood stasis, and effectively resolves the obstruction of blood and qi in the meridians. These three herbs work synergistically as the principal herbs, directly targeting the core pathogenesis of cold-dampness obstruction, and together achieving the effects of warming and dispersing cold, dispelling wind and dampness, unblocking meridians, and relieving pain.
[0037] Half-flavor herb reduces swelling and dissipates nodules, clears heat and cools the blood. While assisting the principal herb in unblocking the meridians and dispersing blood stasis, its heat-clearing and blood-cooling effects can effectively relieve the symptoms of redness, swelling, and heat. Bauhinia bark warms the meridians, unblocks the meridians, invigorates blood and reduces swelling, enhancing the overall effect of the formula in warming and unblocking the meridians. Cynanchum paniculatum dispels wind and dampness, promotes qi circulation and relieves pain, assisting the principal herb, Malus halliana, in enhancing the effect of smoothing qi and promoting blood circulation. Asarum sieboldii invigorates blood, unblocks the meridians, dispels cold and relieves pain, and is good at clearing stagnation in the small meridians. The four herbs are used together as assistant herbs, assisting the principal herb in achieving the effects of warming, unblocking, invigorating blood, and relieving pain.
[0038] The medicinal properties of *Cremastra appendiculata* are to reduce swelling and dissipate nodules, relieving joint swelling caused by arthralgia; *Aralia elata* breaks up blood stasis, relieves pain, promotes diuresis, and detoxifies, enhancing the blood-activating and meridian-clearing effects of the principal medicine; *Smilax china* disperses blood stasis and reduces swelling, and its slightly cold nature can counteract the warming and drying properties of the principal medicine, preventing it from depleting yin fluids; *Clematis armandii* dispels wind and cold, activates blood, and detoxifies, while also clearing the meridians and preventing pathogenic heat; *Aristolochia debilis* disperses blood stasis, relieves pain, promotes qi and blood circulation, assisting *Trichosanthes kirilowii* and *Cynanchum paniculatum* in clearing the meridians and promoting the smooth flow of qi and blood to clear the meridians and remove blood stasis; *Pueraria lobata* seeds activate blood and remove blood stasis, assisting the principal and assistant medicines in clearing the blood vessels; *Ligusticum striatum* and *Spearmintum sibiricum* promote qi and harmonize the middle jiao, dispel wind and cold, and when qi flows, blood flows, enhancing the meridian-clearing ability of the entire formula. All of the above are adjuvant medicines, assisting the principal and assistant medicines in promoting qi and blood circulation, reducing swelling and relieving pain, while also adjusting the properties of the medicines. Finally, borneol is used. Its pungent, cool, and aromatic properties, along with its strong transdermal penetration, allow all the other medicines to penetrate the skin and reach the affected area directly. It also harmonizes the warm and dry nature of the entire formula, preventing the principal, assistant, and adjuvant medicines from being too warm and pungent. Furthermore, it clears heat and relieves pain, alleviating the acute pain of arthralgia. It is an essential medicine for guiding and harmonizing the formula.
[0039] The formula is well-balanced, combining warming and blood-activating effects, as well as dampness removal and meridian unblocking. Together, it achieves the effects of warming the meridians and collaterals, dispelling cold and dampness, promoting blood circulation and removing blood stasis, reducing swelling and relieving pain. When applied externally, it can directly reach the obstructed meridians and joints to relieve symptoms such as pain, numbness, heaviness, and difficulty in flexion and extension of muscles, tendons and joints caused by cold and dampness obstruction.
[0040] Based on the principles of traditional Chinese medicine compatibility, this invention investigated the analgesic and pain-relieving effects of its herbal preparation using hot plate and formaldehyde-induced pain in mice. Experimental results showed that the herbal preparation significantly increased the pain threshold induced by the hot plate method, effectively prolonged the latency period of the first paw lick in formaldehyde-induced pain, and significantly reduced the number of paw licks in formaldehyde-induced pain. The herbal preparation exhibited significant and long-lasting analgesic effects. Furthermore, this invention investigated the anti-drug and anti-swelling effects of its herbal preparation using xylene-induced ear swelling in mice. Experimental results showed that the herbal preparation significantly inhibited the degree of xylene-induced ear swelling in mice, demonstrating a significant anti-swelling effect. Simultaneously, it significantly reduced the levels of inflammatory factors in the ear tissue of swollen mice, exhibiting a significant anti-inflammatory effect. Attached Figure Description
[0041] Figure 1 The results for the pain threshold induced in mice using the hot plate test showed that, compared with the negative control group, *P<0.05, **P<0.01, ****P<0.0001; compared with the experimental group, # P<0.05, # P<0.01.
[0042] Figure 2 The results of the formaldehyde-induced pain experiment in mice are as follows: A represents the time of the first paw licking by mice in each group; B represents the number of paw lickings within 5 minutes in each group; C represents the number of paw lickings within 10 minutes in each group. Compared with the negative control group, *P<0.05, **P<0.01, ***P<0.001; compared with the experimental group, # P<0.05, # P<0.01.
[0043] Figure 3 The results of the xylene-induced mouse ear swelling experiment are shown. A represents the degree of swelling in each group of mice; BC represents the levels of inflammatory factors IL-6 and TNF-α in the ear tissue of each group of mice. Compared with the negative control group, **P<0.01, ***P<0.001; compared with the experimental group, # P<0.05, # P<0.01. Detailed Implementation
[0044] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0045] Example 1
[0046] A traditional Chinese medicine preparation for warming the meridians, dispelling cold, promoting blood circulation, and relieving pain, wherein the preparation is made from the following medicinal materials in parts by weight: 50 parts of *Banbianqi*, 30 parts of *Shancigu*, 55 parts of *Tianwencao*, 55 parts of *Zijingpi*, 45 parts of *Shufu*, 45 parts of *Shuitianqi*, 50 parts of *Shibazheng*, 45 parts of *Ligenxiang*, 45 parts of *Jiejiecha*, 50 parts of *Xuchangqing*, 55 parts of *Yunlanxiang*, 50 parts of *Baimu*, 45 parts of *Ligusticum striatum*, 35 parts of *Zhuifengsan*, 30 parts of *Shanhaitang*, 30 parts of *Dengzhanxixin*, and 35 parts of borneol.
[0047] The traditional Chinese medicine preparation is made from the above-mentioned proportions of Chinese medicinal materials by weight, supplemented with pharmaceutically acceptable excipients, and prepared into a topical dosage form, which includes any one of tincture, emulsion, ointment, liniment, patch, spray, oil, powder, lotion, and paste.
[0048] The traditional Chinese medicine preparation is prepared into an ointment according to the following steps:
[0049] (1) Weigh the spearmint according to the above weight proportions, crush it into coarse powder, pass it through a No. 2 sieve, put it into a volatile oil extractor, add 8 times the amount of purified water, heat and reflux for more than 4 hours to extract the volatile oil, collect the volatile oil and set it aside; keep the residue for later use.
[0050] (2) Weigh out the following ingredients according to the above weight proportions: half-flavor flag, mountain wormwood, astronomical grass, red thorn bark, woodlice, water ginseng, eighteen kinds of disease, root-root incense, joint tea, Xu Changqing, white wood, fan palm seed, wind-chasing umbrella, mountain crabapple, and lamp lanceolata. Grind them into coarse powder, pass them through a No. 2 sieve, and mix them evenly with the residue from step (1). Add 10 times the amount of purified water, soak for more than 1 hour, heat and decoct to extract 3 times. The first decoction is 2 hours, the second is 1.5 hours with 8 times the amount of purified water, and the third is 1 hour with 8 times the amount of purified water. Combine the 3 decoctions, filter, and remove the residue. Concentrate the decoction under reduced pressure to a thick extract with a relative density of 1.20-1.25 for later use.
[0051] (3) Matrix preparation: Take 120 parts by weight of polyethylene glycol 4000, heat it at 80-85℃ until it is completely melted, then add 180 parts by weight of polyethylene glycol 400, stir evenly, keep warm at 80-85℃, add 35 parts by weight of butanediol, 25 parts by weight of 1,2-hexanediol, 10 parts by weight of azone, and 10 parts by weight of menthol in sequence, stir until completely dissolved, then add 0.5 parts by weight of ethylparaben, stir until dissolved, then slowly add 50 parts by weight of purified water, stir evenly, keep warm for later use;
[0052] (4) Slowly add the thick extract prepared in step (2) to the matrix prepared in step (3), stir evenly, cool down to below 40°C, then add the peppermint volatile oil and spearmint volatile oil prepared in step (1), stir evenly, add borneol powder with a particle size of 150-200 mesh, continue stirring for more than 20 minutes to obtain the Chinese medicine paste.
[0053] (5) Adjust the pH of the herbal paste to 6.0-7.0 with triethanolamine, and continue stirring until the temperature of the paste drops below 30°C to obtain the herbal preparation.
[0054] Example 2
[0055] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicinal materials: 30 parts of *Banbianqi*, 20 parts of *Shancigu*, 30 parts of *Tianwencao*, 30 parts of *Zijingpi*, 30 parts of *Shufu*, 30 parts of *Shuitianqi*, 30 parts of *Shibazheng*, 30 parts of *Ligenxiang*, 30 parts of *Jiejiecha*, 30 parts of *Xuchangqing*, 30 parts of *Yunlanxiang*, 30 parts of *Baimu*, 30 parts of *Ligusticum striatum*, 20 parts of *Zhuifengsan*, 20 parts of *Shanhaitang*, 20 parts of *Dengzhanxixin*, and 20 parts of borneol.
[0056] Example 3
[0057] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicinal materials: 60 parts of *Banbianqi*, 50 parts of *Shancigu*, 60 parts of *Tianwencao*, 60 parts of *Zijingpi*, 60 parts of *Shufu*, 60 parts of *Shuitianqi*, 60 parts of *Shibazheng*, 60 parts of *Ligenxiang*, 60 parts of *Jiejiecha*, 60 parts of *Xuchangqing*, 60 parts of *Yunlanxiang*, 60 parts of *Baimu*, 60 parts of *Ligusticum striatum*, 50 parts of *Zhuifengsan*, 50 parts of *Shanhaitang*, 50 parts of *Dengzhanxixin*, and 50 parts of borneol.
[0058] Example 4
[0059] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicinal materials: 35 parts of *Banbianqi*, 22 parts of *Shancigu*, 32 parts of *Tianwencao*, 35 parts of *Zijingpi*, 32 parts of *Shufu*, 32 parts of *Shuitianqi*, 36 parts of *Shibazheng*, 32 parts of *Ligenxiang*, 32 parts of *Jiejiecha*, 32 parts of *Xuchangqing*, 36 parts of *Yunlanxiang*, 35 parts of *Baimu*, 32 parts of *Ligusticum striatum*, 24 parts of *Zhuifengsan*, 22 parts of *Shanhaitang*, 24 parts of *Dengzhanxixin*, and 22 parts of borneol.
[0060] Example 5
[0061] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicinal materials: 40 parts of *Banbianqi*, 25 parts of *Shancigu*, 40 parts of *Tianwencao*, 40 parts of *Zijingpi*, 40 parts of *Shufu*, 40 parts of *Shuitianqi*, 40 parts of *Shibazheng*, 40 parts of *Ligenxiang*, 40 parts of *Jiejiecha*, 40 parts of *Xuchangqing*, 40 parts of *Yunlanxiang*, 40 parts of *Baimu*, 40 parts of *Ligusticum striatum*, 25 parts of *Zhuifengsan*, 25 parts of *Shanhaitang*, 25 parts of *Dengzhanxixin*, and 25 parts of borneol.
[0062] Example 6
[0063] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicinal materials: 60 parts of *Banbianqi*, 45 parts of *Shancigu*, 60 parts of *Tianwencao*, 60 parts of *Zijingpi*, 60 parts of *Shufu*, 60 parts of *Shuitianqi*, 60 parts of *Shibazheng*, 60 parts of *Ligenxiang*, 60 parts of *Jiejiecha*, 60 parts of *Xuchangqing*, 60 parts of *Yunlanxiang*, 60 parts of *Baimu*, 60 parts of *Ligusticum striatum*, 45 parts of *Zhuifengsan*, 45 parts of *Shanhaitang*, 45 parts of *Dengzhan Xixin*, and 45 parts of borneol.
[0064] Example 7
[0065] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicinal materials: 45 parts of *Banbianqi*, 25 parts of *Shancigu*, 50 parts of *Tianwencao*, 50 parts of *Zijingpi*, 40 parts of *Shufu*, 40 parts of *Shuitianqi*, 45 parts of *Shibazheng*, 40 parts of *Ligenxiang*, 40 parts of *Jiejiecha*, 45 parts of *Xuchangqing*, 50 parts of *Yunlanxiang*, 45 parts of *Baimu*, 40 parts of *Ligusticum striatum*, 30 parts of *Zhuifengsan*, 25 parts of *Shanhaitang*, 25 parts of *Dengzhanxixin*, and 30 parts of borneol.
[0066] Example 8
[0067] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicinal materials: 55 parts of *Banbianqi*, 40 parts of *Shancigu*, 60 parts of *Tianwencao*, 60 parts of *Zijingpi*, 50 parts of *Shufu*, 50 parts of *Shuitianqi*, 55 parts of *Shibazheng*, 50 parts of *Ligenxiang*, 50 parts of *Jiejiecha*, 55 parts of *Xuchangqing*, 60 parts of *Yunlanxiang*, 55 parts of *Baimu*, 50 parts of *Ligusticum striatum*, 40 parts of *Zhuifengsan*, 35 parts of *Shanhaitang*, 35 parts of *Dengzhanxixin*, and 40 parts of borneol.
[0068] Test case
[0069] Evaluation of the analgesic, analgesic, anti-inflammatory and swelling-reducing effects of the traditional Chinese medicine preparation of this invention
[0070] 1 Experimental Drugs
[0071] Drug 1: 50 parts of *Banbianqi*, 30 parts of *Shancigu*, 55 parts of *Tianwencao*, 55 parts of *Zijingpi*, 45 parts of *Shufu*, 45 parts of *Shuitianqi*, 50 parts of *Shibazheng*, 45 parts of *Ligenxiang*, 45 parts of *Jiejiecha*, 50 parts of *Xuchangqing*, 55 parts of *Yunlanxiang*, 50 parts of *Baimu*, 45 parts of *Ligusticum chuanxiong*, 35 parts of *Zhuifengsan*, 30 parts of *Shanhaitang*, 30 parts of *Dengzhanxixin*, and 35 parts of borneol were prepared into an ointment according to the method described in Example 1, with each part by weight being 1g.
[0072] Drug 2: Diclofenac Sodium Cream
[0073] Medication 3: Qingpeng Ointment
[0074] 2 Experimental Methods
[0075] 2.1 Hot plate test for induced pain in mice
[0076] Forty female SPF-grade KM mice, weighing 20±2g, were selected. Before the experiment, the normal pain threshold of the mice was screened on a hot plate at (56.0±0.5)℃. Pain was indicated by the appearance of the toe after the mouse licked (bite). Thirty-two mice with a pain threshold of 5-30s were selected and randomly divided into four groups: negative control group, positive control group 1, positive control group 2, and experimental group, with eight mice in each group. The dosage and method of administration for each group are shown in Table 1. The pain threshold of the mice in each group was measured again on the hot plate before administration (marked as 0min), and 30min, 60min, and 90min after administration. If the mouse still had no pain response after 60s on the hot plate, it was counted as 60s.
[0077] Table 1. Administration methods and dosages
[0078]
[0079] 2.2 Formaldehyde-induced pain in mice
[0080] Thirty-two SPF-grade KM mice (half male, half female, weighing 20±2g) were randomly divided into a negative control group, a positive control group 1, a positive control group 2, and an experimental group, with eight mice in each group. The dosage and method of administration for each group are shown in Table 1. Immediately after administration, 30μL of freshly prepared 2.5% formaldehyde solution was subcutaneously injected into the dorsal side of the left hind paw of each mouse. After the injection of formaldehyde solution, the latency period of the first lick of the hind paw, the number of licks of the left hind paw within 5 minutes, and the number of licks of the left hind paw within 10 minutes were observed and recorded.
[0081] 2.3 Xylene-induced mouse ear swelling experiment
[0082] Thirty-two male SPF-grade KM mice, weighing 18-22g (20±2g), were randomly divided into a blank control group (saline), a negative control group (saline), and a positive control group 1 (diclofenac sodium cream, 0.5g / cm³). 2 The mice were divided into three groups: a positive control group (using analgesic plaster for 10 minutes), and an experimental group (using drug 1, 0.5 g / cm²), with eight mice in each group. The corresponding drugs were applied topically or patched onto the right auricle of each group of mice once daily for 3 consecutive days. Before each administration, the application site was cleaned with physiological saline and allowed to dry before administration. One hour after the last administration, except for the blank control group, xylene (0.1 mL / mouse) was evenly applied to the front and back of the right auricle of each mouse to induce inflammation. The mice were then placed in a fume hood and allowed to move freely for 30 minutes before being euthanized. An 8 mm ear patch was punched from the left and right auricles using an 8 mm diameter ear punch and weighed. The degree of swelling and the swelling inhibition rate were calculated for each group. After weighing, ear tissue was collected and homogenized. The levels of IL-6 and TNF-α in the tissue were detected according to the ELISA kit instructions.
[0083] Swelling degree (mg) = Right ear mass - Left ear mass
[0084] Swelling inhibition rate (%) = (Mean ear swelling in the negative control group - Mean ear swelling in the treatment group) / Mean ear swelling in the negative control group × 100%
[0085] 2.4 Statistical Analysis
[0086] All data were analyzed using one-way ANOVA with GraphPad Prism 8.0.2 software, and the LSD method was used for comparisons between groups. All data are expressed as mean ± standard deviation, and P < 0.05 was considered statistically significant.
[0087] 3 Results
[0088] 3.1 Effect of the herbal preparation of this invention on pain induced in mice by the hot plate test
[0089] Before drug administration, there were no significant differences in pain threshold values among the groups of mice (P>0.05). Thirty minutes after drug administration, compared with the negative control group, the pain threshold values of mice in all drug-administered groups increased significantly (P<0.01, P<0.0001). Specifically, the pain threshold values of the experimental groups were significantly higher than those of positive control group 1 (P<0.01) and positive control group 2 (P<0.05). At 60 and 90 minutes after drug administration, compared with the negative control group, the pain threshold values of mice in all drug-administered groups remained at a high level (P<0.05, P<0.01, P<0.0001). Furthermore, the pain threshold values of the experimental groups were consistently significantly higher than those of positive control group 1 (P<0.01) and positive control group 2 (P<0.01, P<0.05). It is noteworthy that the pain threshold values of the experimental group mice did not decrease significantly after 30, 60, and 90 minutes of administration, indicating that the herbal preparation of this invention can not only effectively increase the pain threshold value of mice and has a significant analgesic effect, but also maintain an analgesic effect for a relatively long time. The results are as follows... Figure 1 As shown.
[0090] 3.2 Effect of the herbal preparation of this invention on formaldehyde-induced pain in mice
[0091] Compared with the negative control group, the time to first paw licking was significantly prolonged in all treatment groups (P<0.05, P<0.01, P<0.001). Specifically, the time to first paw licking was significantly longer in the experimental groups than in positive control group 1 (P<0.01) and positive control group 2 (P<0.05). Results are as follows... Figure 2 As shown in Figure A.
[0092] Compared with the negative control group, the number of times mice in the positive control group 2 and the experimental group licked their paws within 5 minutes was significantly reduced (P<0.05, P<0.01). The number of times mice in the positive control group 1 licked their paws within 5 minutes was lower than that in the negative control group, but the difference was not statistically significant (P>0.05). Specifically, the number of times mice in the experimental group licked their paws within 5 minutes was significantly lower than that in the positive control group 1 (P<0.05) and also lower than that in the positive control group 2, but the difference was not statistically significant (P>0.05). Results are as follows. Figure 2 As shown in B.
[0093] Compared with the negative control group, the number of times mice in each treatment group licked their paws within 10 minutes was significantly reduced (P<0.05, P<0.01, P<0.001). Specifically, the number of times mice in the experimental group licked their paws within 10 minutes was significantly lower than that in positive control group 1 (P<0.01) and positive control group 2 (P<0.05). Results are as follows... Figure 2 As shown in C.
[0094] 3.3 Effect of the traditional Chinese medicine preparation of this invention on xylene-induced ear swelling in mice
[0095] Compared with the negative control, the ear swelling of mice in each treatment group was significantly reduced (P<0.001), with the experimental group showing significantly lower ear swelling than positive control group 1 (P<0.01) and positive control group 2 (P<0.05). The swelling inhibition rate of positive control group 1 was 37.15%, that of positive control group 2 was 49.32%, and that of the experimental group was 71.34%. The anti-swelling effect of the herbal preparation of this invention is significantly superior to the two positive control drugs. Results are as follows... Figure 3 As shown in Figure A.
[0096] In addition, this experiment further examined the levels of inflammatory factors in ear tissue. The results are as follows: Figure 3 As shown in BC. Compared with the blank control group, the levels of IL-6 and TNF-α in the ear tissue of mice in the negative control group were significantly increased (P<0.001). Compared with the negative control group, the levels of IL-6 and TNF-α in the ear tissue of mice in each treatment group were significantly decreased (P<0.01, P<0.001). Among them, the levels of IL-6 and TNF-α in the ear tissue of mice in the experimental group were significantly lower than those in positive control group 1 and 2 (P<0.01) and positive control group 2 (P<0.05).
[0097] 4. Conclusion
[0098] This experiment investigated the analgesic and pain-relieving effects of the traditional Chinese medicine preparation of this invention using the hot plate test and formaldehyde test in mice. The results showed that the traditional Chinese medicine preparation significantly increased the pain threshold induced by the hot plate test, effectively prolonged the latency period of the first paw lick in mice induced by the formaldehyde test, and significantly reduced the number of paw licks in mice induced by the formaldehyde test. The traditional Chinese medicine preparation of this invention has significant analgesic and pain-relieving effects and can maintain its analgesic effect for a long time; its analgesic effect is significantly better than that of positive control drugs 1 and 2. Furthermore, this experiment investigated the anti-drug and anti-swelling effects of the traditional Chinese medicine preparation of this invention using xylene-induced ear swelling in mice. The results showed that the traditional Chinese medicine preparation of this invention significantly inhibited the degree of xylene-induced ear swelling in mice, exhibiting a significant anti-swelling effect. Simultaneously, it significantly reduced the level of inflammatory factors in the ear tissue of mice with swollen ears, demonstrating a significant anti-inflammatory effect; its anti-inflammatory and anti-swelling effects are significantly better than those of positive control drugs 1 and 2.
[0099] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims
1. A traditional Chinese medicine preparation for warming the meridians, dispelling cold, promoting blood circulation, and relieving pain, characterized in that, The traditional Chinese medicine preparation is made from the following parts by weight of Chinese medicinal materials: 30-60 parts of *Banbianqi*, 20-50 parts of *Shancigu*, 30-60 parts of *Tianwencao*, 30-60 parts of *Zijingpi*, 30-60 parts of *Shufu*, 30-60 parts of *Shuitianqi*, 30-60 parts of *Shibazheng*, 30-60 parts of *Ligenxiang*, 30-60 parts of *Jiejiecha*, 30-60 parts of *Xuchangqing*, 30-60 parts of *Yunlanxiang*, 30-60 parts of *Baimu*, 30-60 parts of *Ligusticum striatum*, 20-50 parts of *Zhuifengsan*, 20-50 parts of *Shanhaitang*, 20-50 parts of *Dengzhanxixin*, and 20-50 parts of borneol.
2. The traditional Chinese medicine preparation for warming the meridians, dispelling cold, promoting blood circulation, and relieving pain as described in claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following medicinal materials in parts by weight: 40-60 parts of *Banbianqi*, 25-45 parts of *Shancigu*, 40-60 parts of *Tianwencao*, 40-60 parts of *Zijingpi*, 40-60 parts of *Shufu*, 40-60 parts of *Shuitianqi*, 40-60 parts of *Shibazheng*, 40-60 parts of *Ligenxiang*, 40-60 parts of *Jiejiecha*, 40-60 parts of *Xuchangqing*, 40-60 parts of *Yunlanxiang*, 40-60 parts of *Baimu*, 40-60 parts of *Ligusticum striatum*, 25-45 parts of *Zhuifengsan*, 25-45 parts of *Shanhaitang*, 25-45 parts of *Dengzhanxixin*, and 25-45 parts of borneol.
3. The traditional Chinese medicine preparation for warming the meridians, dispelling cold, promoting blood circulation, and relieving pain as described in claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following medicinal materials in parts by weight: 50 parts of *Banbianqi*, 30 parts of *Shancigu*, 55 parts of *Tianwencao*, 55 parts of *Zijingpi*, 45 parts of *Shufu*, 45 parts of *Shuitianqi*, 50 parts of *Shibazheng*, 45 parts of *Ligenxiang*, 45 parts of *Jiejiecha*, 50 parts of *Xuchangqing*, 55 parts of *Yunlanxiang*, 50 parts of *Baimu*, 45 parts of *Ligusticum striatum*, 35 parts of *Zhuifengsan*, 30 parts of *Shanhaitang*, 30 parts of *Dengzhan Xixin*, and 35 parts of borneol.
4. A traditional Chinese medicine preparation for warming the meridians, dispelling cold, and promoting blood circulation as described in any one of claims 1 to 3, characterized in that the traditional Chinese medicine preparation is made from the above-mentioned parts by weight of traditional Chinese medicinal materials as raw materials, supplemented with pharmaceutically acceptable excipients, and prepared into an external dosage form, wherein the external dosage form includes any one of tincture, emulsion, ointment, liniment, patch, spray, oil, powder, lotion, and paste.
5. A method for preparing a traditional Chinese medicine preparation for warming the meridians, dispelling cold, and promoting blood circulation as described in any one of claims 1 to 3, characterized in that, The traditional Chinese medicine preparation is prepared according to the following steps: (1) Weigh the spearmint according to the above weight proportions, crush it into coarse powder, pass it through a No. 2 sieve, put it into a volatile oil extractor, add 8-10 times the amount of purified water, heat and reflux for more than 4 hours to extract the volatile oil, collect the volatile oil and set it aside; keep the residue for later use. (2) Weigh out the following ingredients according to the above weight proportions: half-flavor flag, mountain wormwood, astronomical grass, red thorn bark, woodlice, water ginseng, eighteen kinds of disease, root-leaved incense, jointed tea, Xu Changqing, white wood, fan palm seed, wind-chasing umbrella, mountain crabapple, and lamp lanceolata. Grind them into coarse powder, pass them through a No. 2 sieve, and mix them evenly with the residue from step (1). Add 10-12 times the amount of purified water, soak for more than 1 hour, heat and decoct to extract 3 times. The first decoction is 1.5-2 hours, the second is 1-1.5 hours with 8-10 times the amount of purified water, and the third is 1-1.5 hours with 8-10 times the amount of purified water. Combine the 3 decoctions, filter, and remove the residue. Concentrate the decoction under reduced pressure to a thick extract with a relative density of 1.20-1.25 for later use. (3) Matrix preparation: Take 100-150 parts by weight of polyethylene glycol 4000, heat it at 80-85℃ until it is completely melted, then add 150-200 parts by weight of polyethylene glycol 400, stir evenly, keep warm at 80-85℃, add 30-40 parts by weight of butanediol, 20-30 parts by weight of 1,2-hexanediol, 5-15 parts by weight of azone, and 5-15 parts by weight of menthol, stir until completely dissolved, then add 0.5-1.5 parts by weight of ethylparaben, stir until dissolved, then slowly add 40-70 parts by weight of purified water, stir evenly, keep warm for later use; (4) Slowly add the thick extract prepared in step (2) to the matrix prepared in step (3), stir evenly, cool down to below 40°C, then add the peppermint volatile oil and spearmint volatile oil prepared in step (1), stir evenly, add borneol powder with a particle size of 150-200 mesh, continue stirring for more than 20 minutes to obtain the Chinese medicine paste. (5) Adjust the pH of the herbal paste to 6.0-7.0 with triethanolamine, and continue stirring until the temperature of the paste drops below 30°C to obtain the herbal preparation.